Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:

Compliance with Online Adaptive Radiation Therapy process [ Time Frame: From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days) ] [ Designated as safety issue: No ]

A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation

Secondary Outcome Measures:

Pattern of failure and competing risks analysis [ Time Frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial ] [ Designated as safety issue: No ]

Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

Disease Free survival [ Time Frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial ] [ Designated as safety issue: No ]

Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.

Quality of Life [ Time Frame: Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment. ] [ Designated as safety issue: No ]

Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.

Late normal tissue effects [ Time Frame: Between 3 months and 3 years after the completion of radiation treatment ] [ Designated as safety issue: Yes ]

Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.

Time to Local Bladder Failure [ Time Frame: From date of enrolment to date of local bladder failure ] [ Designated as safety issue: No ]

Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

A radical dose of radiotherapy to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 treatment days.

Conventional plan is used to deliver treatment for fractions 1 to 7 using a standard planning approach and a CTV to PTV margin of 1.5cm.

Adaptive plan is used to deliver treatment for fractions 8 through 32 using the same standard techniques as for fractions 1 to 7 but using one of three specific CTV volumes,namely: small, average or large. In all these cases the CTV to PTV margin is 0.7cm. Image guidance using a treatment unit based verification CT unit (Cone Beam CT or CT on Rails)based on soft tissue delineation is used to position the treatment fields and select the plan to best cover the CTV.

Detailed Description:

This is a single-arm multicentre feasibility trial in which the primary aim is to determine the compliance rate of patients to online adaptive radiotherapy for muscle invasive bladder cancer over multiple Australian and New Zealand centres. The compliance rate is defined as the proportion of patients successfully completing treatment without a major protocol deviation.

Subject to the accrual being at least 40 patients in the first 2 years, accrual will continue until a total of 50 patients have been accrued. If this accrual target is not met, then consideration will be given to stopping the trial early due to poor accrual. Each patient will be followed-up until 2 years after the last patient's date of accrual. Assessments for toxicity and recurrence or progression will take place at four weeks after completion of treatment, then three monthly from the end of treatment for the first 12 months and then 6 monthly thereafter.

Participants capable of childbearing are using adequate contraception.

Radiotherapy must be able to be commenced within 12 weeks of surgery.

Available for follow up.

Exclusion Criteria:

Women who are pregnant or lactating.

Previous pelvic radiotherapy

Previous cystectomy

A small contracted bladder

Unilateral or bilateral hip replacement

Small cell histology

Clinical or radiological evidence of nodal or distant metastases

Presence of indwelling urinary catheter

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142102